Cryolife, Inc.
Cryolife, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2019, with 14 FDA device recalls on record.
Top product codes for Cryolife, Inc.
FDA recalls by Cryolife, Inc.
10 most recent of 14- Z-0384-2022 — BioGlue Surgical Adhesive, Model BG3510-5-G
- Z-0652-2021 — CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
- Z-0653-2021 — CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.
- Z-1073-2019 — On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
- Z-0121-2019 — CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Z-2556-2018 — BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
- Z-2271-2018 — Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- Z-2272-2018 — Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Z-2623-2017 — BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Z-1219-2019 — CryoPatch SG Pulmonary Hemi-Artery Patch
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cryolife, Inc.
- K183635 — PhotoFix Decellularized Bovine Pericardium
- K172085 — PhotoFix Decellularized Bovine Pericardium
- K162506 — PhotoFix Decellularized Bovine Pericardium
- K132105 — PERCLOT TOPICAL
- K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX
- K101587 — PROPATCH SOFT TISSUE REPAIR MATRIX
- K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
- K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
- K091626 — CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
- K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT
- K033484 — HUMAN HEART VALVE, CRYOVALVE SG
- K061892 — PROPATCH SOFT TISSUE REPAIR MATRIX
Data sourced from openFDA. This site is unofficial and independent of the FDA.